Argenx Se SEC Filings

argenx reported a transformational 2025, driven by its VYVGART franchise. Full-year global product net sales reached $4.2 billion, up about 90% from 2024, lifting total operating income to $4.25 billion. This delivered $1.05 billion in operating profit, marking the company’s first year of operating profitability.

Net profit for 2025 was $1.29 billion, with basic earnings of $21.08 per share, up from $13.92. Fourth-quarter product net sales were $1.29 billion, and argenx treated roughly 19,000 patients globally with VYVGART while advancing multiple Phase 3 programs and label expansions in myasthenia gravis, CIDP, and other autoimmune diseases.

argenx reported positive topline Phase 3 results from its ADAPT OCULUS trial of VYVGART in adults with ocular myasthenia gravis (oMG). The study met its primary endpoint (p=0.012), with patients on VYVGART showing a 4.04-point mean improvement in MGII patient-reported ocular scores at week 4 versus 1.99 points on placebo.

Patients treated with VYVGART experienced marked reductions in key ocular symptoms, including double vision and drooping eyelids. VYVGART was well tolerated with a favorable safety profile and no new safety concerns, consistent with prior studies. argenx plans to submit a supplemental Biologics License Application for VYVGART in oMG to the U.S. FDA by the end of the third quarter of 2026.

ADAPT OCULUS is described as the first registrational study specifically designed for a targeted therapy in oMG, addressing a rare disease with significant unmet need and no currently approved targeted treatments. Data from the trial will be presented at an upcoming medical meeting.

argenx reported positive topline Phase 3 results from its ADAPT OCULUS trial of VYVGART in adults with ocular myasthenia gravis (oMG). The study met its primary endpoint (p=0.012), with patients on VYVGART showing a 4.04-point mean improvement in MGII patient-reported ocular scores at week 4 versus 1.99 points on placebo.

Patients treated with VYVGART experienced marked reductions in key ocular symptoms, including double vision and drooping eyelids. VYVGART was well tolerated with a favorable safety profile and no new safety concerns, consistent with prior studies. argenx plans to submit a supplemental Biologics License Application for VYVGART in oMG to the U.S. FDA by the end of the third quarter of 2026.

ADAPT OCULUS is described as the first registrational study specifically designed for a targeted therapy in oMG, addressing a rare disease with significant unmet need and no currently approved targeted treatments. Data from the trial will be presented at an upcoming medical meeting.

argenx SE reported that the U.S. FDA has accepted for priority review a supplemental Biologics License Application for its therapy VYVGART (efgartigimod IV) to treat adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis. The FDA set a PDUFA target action date of May 10, 2026, defining when it expects to complete its review.

The application is backed by the Phase 3 ADAPT SERON trial in 119 adults, which met its primary endpoint with a statistically significant improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) versus placebo (p=0.0068). Patients on VYVGART showed a mean 3.35‑point MG-ADL improvement at week 4, with benefits seen across MuSK+, LRP4+, and triple seronegative subgroups. VYVGART was well-tolerated, with a safety profile consistent with prior use in AChR-Ab seropositive gMG and no new safety concerns identified.

argenx SE reported preliminary full-year 2025 global product net sales of $4.15 billion, a 90% year-over-year increase, including about $1.29 billion in fourth quarter sales. The growth is driven by VYVGART, with approximately 19,000 patients on treatment across approved indications in generalized myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and primary immune thrombocytopenia in Japan.

For 2026, argenx set strategic priorities under its “Vision 2030,” aiming ultimately to treat 50,000 patients, secure 10 labeled indications, and advance five pipeline candidates into Phase 3. The company expects four registrational readouts in 2026, including the first for empasiprubart, and plans to have 10 molecules in clinical development by year-end. Leadership changes are planned, with COO Karen Massey slated to become CEO and Tim Van Hauwermeiren to move to non-executive chair, subject to shareholder approval in May 2026.

argenx SE is registering additional ordinary shares to be issued under its argenx Equity Incentive Plan, as amended. These shares will be used for equity-based compensation to eligible employees and other participants, aligning their interests with the company’s long-term performance.

The registration statement incorporates by reference argenx’s Annual Report on Form 20-F for the year ended December 31, 2024, along with multiple Form 6-K reports filed in 2025. It also describes how Dutch law and the company’s Articles of Association provide indemnification and insurance protection for directors and certain officers, subject to limits such as exclusions for willful misconduct or improper personal benefit.

argenx SE filed a Form 6-K as a foreign private issuer to furnish investors with a new press release and an investor presentation dated October 30, 2025. These documents are attached as Exhibits 99.1 and 99.2 and provide updated company information for the market.

The furnished materials are also incorporated by reference into argenx’s existing Form S-8 registration statements, becoming part of those filings from the date this Form 6-K is filed, unless later superseded. This ties the latest investor communications directly into the company’s equity compensation registration framework.